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VisuMax Femtosecond Laser - P150040/S003

Image of the device.

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: VisuMax Femtosecond Laser
PMA Applicant: Carl Zeiss Meditec, Inc.
Address: 5160 Hacienda Dr., Dublin, CA 94568
Approval Date: October 4, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150040s003a.pdf

What is it? The VisuMax Femtosecond Laser is an ophthalmic surgical laser designed to create small cuts (incisions) in the transparent layer on the front of the eye (the cornea). It is used in the VisuMax small-incision lenticule extraction or SMILE procedure, which is a surgical treatment for nearsightedness (myopia) with or without astigmatism. Supplement 3 is for the approval of the surgical treatment with astigmatism.

How does it work? The eye surgeon uses the VisuMax Femtosecond Laser to cut a disc-shaped piece of corneal tissue (lenticule), which is thicker in the center and thinner at the edge. The eye surgeon removes this tissue with surgical instruments. The removal of this tissue flattens the center of the cornea and results in the reduction or elimination of nearsightedness and astigmatism.

When is it used? The VisuMax Femtosecond Laser is indicated for use in the SMILE procedure for the reduction or elimination of nearsightedness with or without astigmatism in patients who are 22 years of age or older and has:

  • nearsightedness of -1.00 to -10.00 diopter in power,
  • astigmatism of -0.75 to -3.00 diopter in power,
  • a maxmum of total prescription (nearsightedness plus half of the astigmatism) of no more than -10.00 diopters in power; and
  • stable nearsightedness and astigmatism that has changed by no more than 0.50 diopter in power in the year before surgery

What will it accomplish? The VisuMax Femtosecond Laser is intended to reduce or eliminate nearsightedness with or without astigmatism when used in patients as described above. In a clinical study of 348 patients, all but five had uncorrected (without glasses or contacts) visual acuity of 20/40 or better, and 84 percent had uncorrected visual acuity of 20/20 or better. Complications after surgery included moderate to severe glare, moderate to severe halos, dry eye, and debris at the site of tissue removal.

When should it not be used? The VisuMax SMILE procedure should not be used with any of the following conditions:

  • insufficient corneal tissue thickness for the amount of correction needed,
  • abnormal findings on the map of the surface curvature of your cornea that indicate general thinning of the cornea and/or a cone-shaped bulge in the center of cornea (keratoconus),
  • signs of increasing or unstable nearsightedness or signs of corneal conditions that can lead to a thinning and bulging of the cornea,
  • a distorted or unfocused image mirrored on the eye during measurements that may indicate an irregular or unstable corneal surface,
  • severe dry eye,
  • an active eye infection or inflammation,
  • a Herpes infection that affected your eyes or problems with your eyes resulting from a past infection,
  • an active autoimmune disease or connective tissue disease (e.g., rheumatoid arthritis, systemic lupus erythematosus),
  • uncontrolled build-up of high pressure in the eye (glaucoma),
  • uncontrolled high blood sugar (diabetes).

Additional information (including warnings, precautions, and adverse events):